Many sellers outside the EU receive a lab report from their factory with "REACH compliant" or "SVHC: pass" on the cover. Then a marketplace, a customer or an authority asks whether the product meets the REACH restrictions, and the report turns out not to answer that question.
The reason is that REACH has two different lists. The Candidate List of substances of very high concern (SVHC) creates a duty to inform. Annex XVII contains restrictions with legal limits that a product must meet before it can be sold in the EU. A screening for one list says little about the other.
This article explains the difference, which Annex XVII restrictions hit common consumer products, and how to work out which test your product needs.
- Two lists, two questions
- What an SVHC screening does and does not show
- Annex XVII restrictions that hit consumer products
- How to decide which test you need
- Who is responsible when you sell from outside the EU
- What inspections find
- Checklist
Two lists, two questions
REACH is Regulation (EC) No 1907/2006. For products such as clothing, jewellery, toys or kitchenware, two parts of it matter most.
The Candidate List (SVHC) holds more than 250 substances of very high concern. Being on the list is not a ban. It triggers information duties. If an article contains a listed substance above 0.1% by weight, the supplier must give business customers enough information for safe use, at least the name of the substance (Article 33(1)). A consumer who asks must get the same information free of charge within 45 days (Article 33(2)). Suppliers of such articles must also notify them in ECHA's SCIP database, a duty under the Waste Framework Directive (Article 9(1)(i) of Directive 2008/98/EC) since 5 January 2021. A notification to ECHA under Article 7(2) applies only above one tonne of the substance per year in those articles.
Annex XVII lists restrictions. A substance in an article for which Annex XVII has a restriction may not be placed on the market unless it meets the conditions of that restriction (Article 67(1)). There is no tonnage threshold. A single necklace that releases too much nickel may not be sold.
| Candidate List (SVHC) | Annex XVII | |
|---|---|---|
| What it is | List of substances of very high concern | List of restrictions with conditions and limits |
| Legal effect | Information and notification duties | The product may not be sold if it exceeds the limit |
| Typical threshold | 0.1% by weight per article | Per restriction, often 1 to 1,000 mg/kg, or a release limit |
| Main articles | Articles 7(2), 33 and 59 REACH | Article 67 and Annex XVII REACH |
The 0.1% threshold applies to each article in a product, not to the product as a whole. If a jacket has a zip, buttons and a sewn-on label, each of those counts on its own. The Court of Justice confirmed this in case C-106/14 of 10 September 2015.
What an SVHC screening does and does not show
An SVHC screening checks whether listed substances are present above 0.1%. A pass tells you that you probably have no Article 33 duty for the substances that were tested. It does not tell you that the product meets Annex XVII, for three reasons.
First, the limits are of a different order. 0.1% is 1,000 mg/kg. Annex XVII limits are often far lower: 3 mg/kg for chromium VI in leather, 1 mg/kg for certain PAHs (polycyclic aromatic hydrocarbons) in rubber and plastic parts, 30 mg/kg for amines from azo dyes. A screening designed to find 1,000 mg/kg can miss a product that fails at 3.
Second, several restrictions are not about content but about release. The nickel restriction sets how much nickel may come off the surface of a ring or a rivet button per week. That needs a migration test, not a content analysis.
Third, many restricted substances are not on the Candidate List, or a screening package does not include them. Nickel and most amines from azo dyes are examples. Some chromium VI compounds are on the list, but a screening at 0.1% says nothing about 3 mg/kg in leather.
The reverse also applies. An Annex XVII test does not tell you whether you have an information duty for an SVHC. Which test you need depends on the question you have to answer.
Annex XVII restrictions that hit consumer products
The table below shows the restrictions that most often apply to the products our clients sell. The entry numbers refer to Annex XVII, so you can look up the exact conditions yourself.
| Product group | Restriction | Limit | Entry |
|---|---|---|---|
| Jewellery, watches, metal parts in skin contact | Nickel release | 0.5 µg/cm² per week; 0.2 for piercing posts | 27 |
| Jewellery | Lead in any individual part | 0.05% by weight | 63 |
| Metal parts of jewellery and hair accessories | Cadmium | 0.01% by weight of the metal | 23 |
| Textiles and leather in skin contact | Amines from azo dyes | 30 mg/kg | 43 |
| Clothing, textiles and footwear | CMR substances (substances that can cause cancer, damage DNA or harm fertility), such as formaldehyde, heavy metals and certain phthalates | Per substance, for example formaldehyde 75 mg/kg | 72 |
| Leather in skin contact | Chromium VI | 3 mg/kg | 47 |
| Plasticised plastics, such as PVC | Phthalates DEHP, DBP, BBP, DIBP | 0.1% combined in the plasticised material | 51 |
| Toys and childcare articles that can go in the mouth | Phthalates DINP, DIDP, DNOP | 0.1% of the plasticised material | 52 |
| Rubber and plastic parts in skin or mouth contact | PAHs | 1 mg/kg; 0.5 mg/kg in toys and childcare articles | 50 |
| PVC articles | Lead | 0.1% by weight of the PVC, since 29 November 2024 | 63 |
| Listed plastics and paints | Cadmium | 0.01% by weight | 23 |
| Furniture, wood-based and other articles (not second-hand, not covered by entry 72) | Formaldehyde release | 0.062 mg/m³ for furniture and wood-based articles; 0.080 mg/m³ for other articles, since 6 August 2026 | 77 |
| Clothing, accessories and footwear for the public | PFHxA and related substances | 25 ppb; 1,000 ppb for related substances, since 10 October 2026 | 79 |
Two newer restrictions are worth knowing about. The PFHxA restriction applies to clothing, accessories and footwear for the general public placed on the market from 10 October 2026, and to other textiles and leather for the public from 10 October 2027. From 11 May 2027, articles for consumers or professional users may not contain 0.1% or more of 2,4-dinitrotoluene (entry 83).
Toys also fall under the Toy Safety Directive, which the new Toy Safety Regulation (EU) 2025/2509 will replace. Both set their own chemical requirements on top of REACH. Our article on EN 71 and importing toys covers those.
Not sure which restrictions apply to your product? Our EU Product Compliance Check lists the rules and tests per product, so you do not pay for tests you do not need.
How to decide which test you need
REACH does not require a lab test as such. It requires the product to meet the limits. In practice it is hard to show that without a test report. Under the General Product Safety Regulation (GPSR), the manufacturer must also carry out an internal risk analysis that takes the product's composition into account, and keep technical documentation (Articles 6(1)(a) and 9(2) of Regulation (EU) 2023/988). These steps help you choose.
- List every material per component. Fabric, lining, zip, buttons, print, metal clasp, plastic housing, rubber grip, coating. A test is done per material, not per product. A T-shirt with a metal button needs the button tested as well.
- Match each material to the restrictions. Use the table above. Metal in skin contact means nickel, and for jewellery lead and cadmium. Textile and leather in skin contact means azo dyes and the CMR list. Soft plastic means phthalates, PAHs and, for PVC, lead.
- Ask the lab for an Annex XVII package per material, with named methods. Some restrictions name the method. For azo dyes these are EN ISO 14362-1 and -3 for textiles and EN ISO 17234-1 and -2 for leather (Appendix 10). Chromium VI in leather is measured with EN ISO 17075, and nickel release with the CEN standard EN 1811.
- Add an SVHC screening when you need it. For example when a business customer or marketplace asks for an Article 33 statement, or when you want to check whether a SCIP notification applies. Ask for results per component.
- Check the report before you file it. Does it name your product, model and materials? Is it recent? Is the lab accredited to ISO/IEC 17025? Do the limits match the current version of Annex XVII, including the newer limit for lead in PVC (entry 63) and the new entries for formaldehyde (77) and PFHxA (79)?
- File the report in your technical file and refer to it in your risk analysis. Our article on the GPSR risk assessment shows how.
Our article on which product test you need for the EU covers the wider question of safety tests beyond chemicals.
Who is responsible when you sell from outside the EU
Under REACH, an importer is a person established in the EU who is responsible for the import (Article 3(11)). A company outside the EU cannot be a REACH importer itself. ECHA states that responsibility lies with the importers established in the EU. When a non-EU seller ships directly to EU consumers, ECHA's guidance does not clearly say who that importer is.
What is clear is that authorities treat an online offer aimed at EU customers as making the product available on the EU market (Article 6 of Regulation (EU) 2019/1020), and REACH is one of the laws they enforce under that regulation. Every consumer product covered by the GPSR needs a responsible economic operator in the EU (Article 16(1)). Where the risks call for it, that operator must regularly check that the product matches its technical documentation, and must give authorities evidence of those checks on request (Article 16(2)). In practice the test reports are what that person shows when an authority asks.
Selling in the EU from outside the EU? Our EU Authorised Representative service under the GPSR gives you that EU contact point, and we review your technical documentation, including your test reports.
What inspections find
Chemical risks are the most common reason for EU product alerts. In 2025 they accounted for 53% of all alerts in the Safety Gate system (Safety Gate 2025 report). Our article on the EU Safety Gate explains what such an alert means for a seller.
In ECHA's most recent enforcement project on imported products, inspectors in 29 countries carried out 2,603 inspections. Restricted substances exceeded the legal limits in 16% of the products checked for restrictions. Jewellery, toys and textiles had the most problems, and imported jewellery still often contained restricted heavy metals, especially nickel (ECHA Enforcement Forum, December 2025).
Penalties are set by each member state and must be effective, proportionate and dissuasive (Article 126 REACH). The more common consequence for a small seller is practical: goods held at the border, a listing removed, or a recall.
Checklist
- List all materials per component of your product.
- Match each material to the Annex XVII restrictions in the table.
- Ask the lab for an Annex XVII test per material, with the methods named in the report.
- Add an SVHC screening per component if a customer or marketplace asks, or to check your Article 33 and SCIP duties.
- Check that the report names your product and materials, comes from an ISO/IEC 17025 accredited lab and uses the current limits.
- File the reports in your technical file and refer to them in your risk analysis.
- Check again when your supplier changes a material, a colour or a coating.
Want to know which tests your product needs before you order them? Start with our EU Product Compliance Check. Already have reports? Our test report review checks whether they cover the right requirements.
For a broader introduction to REACH for importers, see our article on REACH compliance for non-food importers.
Sources
- Regulation (EC) No 1907/2006 (REACH), Articles 3(11), 7(2), 33, 59, 67 and 126, and Annex XVII, entries 23, 27, 43, 47, 50, 51, 52, 63, 72, 77, 79 and 83 with Appendices 10 and 12. EUR-Lex
- Commission Regulation (EU) 2023/923 (lead in PVC), (EU) 2023/1464 (formaldehyde), (EU) 2024/2462 (PFHxA) and (EU) 2026/859 (2,4-dinitrotoluene), amending Annex XVII.
- Directive 2008/98/EC on waste, Article 9(1)(i), as amended by Directive (EU) 2018/851 (SCIP). EUR-Lex
- Court of Justice of the EU, case C-106/14, FCD and FMB, judgment of 10 September 2015.
- Regulation (EU) 2023/988 (GPSR), Articles 6(1)(a), 9(2) and 16. EUR-Lex
- Regulation (EU) 2019/1020 on market surveillance, Article 6 and Annex I. EUR-Lex
- ECHA, Candidate List of substances of very high concern. echa.europa.eu
- ECHA Enforcement Forum, REF-12 project on imported products, results published December 2025.
- European Commission, Safety Gate 2025 report. op.europa.eu
- Consulted October 2026.
